The Medicines and Healthcare products Regulatory Agency (MHRA) this morning named Jack3d and, “all other DMAA containing products” as unlicensed medicines that, “need to be removed from the UK market amid concerns of potential risks to public safety.”
An MHRA spokesperson told us the agency had been awaiting the appeal verdict before condemning DMAA.
The appeal was made by an unnamed online retailer of Jack3D after it received one of eight warning letters issued by the MHRA earlier in the year.
“We are glad that we have been able to confirm the illegal status of Jack3D and DMAA after the ruling determined that Jack3D was indeed an unlicensed medicine,” he said.
“Our Borderline and Enforcement teams are remaining vigilant on this and further retailers have been identified.”
These included both online and walk-in retailers.
DMAA (1,3-dimethylamylamine/methylhexaneamine) consumption has been linked to narrowing of the arteries, increased heart rate, shortness of breath, heart attacks, psychiatric disorders and cerebral haemorrhage.
Impasse passed
Peter Berry Ottoway, technical director for the Council for Responsible Nutrition UK (CRN-UK)– which long ago condemned the ingredient for lacking a legal footing in the European Union – said the MHRA move, “made sense”.
“This resolves an anomaly where an impasse had been reached between the MHRA and the UK Food Standards Agency about whether DMAAA was a food or pharmaceutical ingredient."
“It has been ruled an illegal medicine as we said it was all along. It will be interesting to see how this plays out in other EU member states now.”
The UK group is not affiliated with CRN US which, like most of the US-based trade groups, has remained largely silent as the DMAA saga has rumbled on.
DMAA is typically used as a pre-workout supplement by gym-goers and as a weight loss aid but has come under scrutiny over safety concerns and whether or not it is sourced from the geranium plant.
It has been banned or warned against in many European countries, Australia, New Zealand, the US and Canada, causing widespread product removal and reformulation, not to mention lawsuits, although USPlabs and others continue to defend DMAA, and sell products containing it in many markets.
WADA banned
In the wake of the Olympics, the MHRA also noted the fact DMAA has caused more doping offences (137) for elite athletes in the past two years than another other substance on the World Anti-Doping Agency’s (WADA) prohibited list of more than 240 substances.
Graham Arthur, legal director at the UK Anti-Doping Agency (UKADA) said the MHRA action was, “a significant step forward for all competitive athletes as DMAA is a banned substance ‘in-competition’ that frequently appears in over the counter and internet bought products but not clearly on the label.”
For the more ‘regular’ user, David Carter, the MHRA’s Medicines Borderline Section manager, said: “People need to be aware when choosing their sports supplements. These products may claim to increase performance but contain powerful ingredients which can have serious side-effects.
The MHRA recently issued warning letters to 84 companies marketing sports supplements because they were found to contain dangerous ingredients such as steroids, stimulants and hormones. Most of them were sold online.